Quality of brands of atorvastatin calcium tablets marketed in Lagos, Nigeria
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Date
2012-10-03
Authors
Akinleye, M.O.
Idris, O.
Nwachukwu, P.N.
Oyetunde, O.O.
Journal Title
Journal ISSN
Volume Title
Publisher
International Scholars journals
Abstract
This study investigated the quality of atorvastatin calcium tablets marketed in Lagos, Nigeria, by evaluating and comparing their physico-chemical profiles. Evaluation of physico-chemical parameters viz: uniformity of weight, hardness, friability and disintegration test was carried out according to British Pharmacopoeia. Assay of active ingredient and in-vitro dissolution evaluation were conducted using USP Apparatus 2 satisfying the general conditions for film tablets as stipulated in official books. Tablets and dissolution samples were analyzed using a modification of the validated High performance liquid chromatographic method developed by Stanisz and Lukas. All the three brands met the standards for the physical qualities of a satisfactory tablet, and all had percentage purities within the 90 to 110% range. Only brands AT and CT had released ≥75% of label claim of atorvastatin calcium within 45 min, as specified in the B.P for conventional tablets. Thus, brand BT which had barely released 70% of its label claim at 60 min failed dissolution test. We concluded that out of the 3 brands of immediate release atorvastatin calcium tablets available in the market at the time of the study, only 2 passed all the pharmacopoeia tests for satisfactory quality. Thus, only these can be interchanged in clinical practice.
Description
Staff publications
Keywords
Atorvastatin , in vitro bioequivalence , switchability , Quality , safety , Research Subject Categories::NATURAL SCIENCES::Chemistry
Citation
Akinleye, M.O, Idris, O., Nwachukwu, P.N. and Oyetunde, O.O. (2012). Quality of brands of atorvastatin calcium tablets marketed in Lagos, Nigeria.